Pre-op Paravertebral Blocks to Decrease Post-op Pain Following Mastectomy With Immediate Tissue Expander (TE) Reconstruction

NCT02161705 | Terminated Phase 3 Results

• 2 other identifiers: NA_00075957311945
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective To determine if post-operative static pain scores differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks. Post-operative pain scores will be measured by a 0-10 Likert scale 6 hours after the end of surgery while the patient is still hospitalized (post-operative day 0). This will be patient-provided data. Unblinded data analysis will compare scores between treatment and control groups. Secondary Objectives To determine if post-operative moving pain scores, opioids use, nausea, and sleep interference differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks. Pain score, opioids use, nausea, and sleep interference data will be collected via patient self-report. When possible (i.e., while hospitalized) objective data on opioids and other pain medication administered to the patient will be used. Tertiary Objectives To determine if long-term changes in Quality of Life scores \[the RAND-36 Health Survey, Disability of the Arm, Shoulder, and Hand (Quick DASH) questionnaire, and Breast-Q scores\] differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks. This data will be collected via validated questionnaires through patient interviews at 3-months, 2-years, and 4-years (±14 days) after surgery. Once enrolled in the study, participants will be encouraged to remain in the study for the 4 years following surgery in order to get final pain scores and quality-of-life/health outcome survey information. Participants who cannot be contacted after several phone attempts and the sending of 2 certified letters via US Postal Service for 3-month, 2-year, and/or 4-year outcome assessments will be considered lost to follow-up.

Conditions

Postoperative Pain; Postoperative Nausea and Vomiting; Quality of Life

Keywords

Immediate breast reconstruction; pain control; post mastectomy pain control

Outcome Measures

Primary Outcomes (1)

• Postoperative Static Pain Score

  To determine if post-operative static pain scores differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander breast reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks. Post-operative pain, pain medication/narcotic use, and assessment for adverse events (AEs)/serious adverse events (SAEs) will be assessed the Day of surgery through post-operative Day 7. A clinic visit occurs on Day 7 where additional data collected (updated medical history, pain medication/narcotic use, AEs/SAEs, and study questionnaires). Static pain refers to pain when the patient is at rest. Patients report pain on a scale of 0-10 were in 0 represents no pain and 10 the most severe pain they have experienced.

  Day of Surgery through Day 7

Secondary Outcomes (1)

• Quality of Life Scores as Assessed by the BREAST-Q Score

  Postoperative Day-30, Day-90 , 2-years, and 4-years (±14 days) after surgery.

Study Arms (2)

Ropivacaine Group

EXPERIMENTAL

Paravertebral block injections of study solution will occur using the landmark-based classic technique with a 22-gauge Tuohy needle to deliver 0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg).

Drug: Ropivacaine

Saline Group

PLACEBO COMPARATOR

Paravertebral block injections of normal saline (up to 0.8 mL/kg) will occur using the landmark-based classic technique with a 22-gauge Tuohy needle. Immediately after completion of the injections, patients will be repositioned supine and general anesthesia induced in the standard manner.

Drug: Saline

Interventions

Ropivacaine DRUG

0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg) administered in paravertebral block

Also known as: Naropin

Ropivacaine Group

Saline DRUG

Up to 0.8 mL/kg of normal saline administered

Also known as: Normal Saline

Saline Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be Female aged 18-100 years.
• Choose mastectomy followed by bilateral immediate tissue expander breast reconstruction.
• Have no inflammatory breast cancers.
• Be aware of the nature of her malignancy.
• Understand the study purpose, requirements, and risks.
• Be able and willing to give informed consent.

You may not qualify if:

• Any concurrent opioid analgesic use (baseline opioid use must be 0 to be eligible).
• Liver dysfunction and/ or cirrhosis.
• Renal insufficiency, with creatinine greater than 1.5 mg/mL.
• Patients weighing less than 50 Kg.
• Concurrent use of the SSRI antidepressant fluvoxamine (Luvox).

Sponsors & Collaborators

• Johns Hopkins University: lead
• The Plastic Surgery Foundation: collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting; Agnosia

Interventions

Ropivacaine; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Pathik Aravind
• Organization: Johns Hopkins University School of Medicine

paravin1@jhmi.edu

4437879385

Study Officials

• Gedge D Rosson, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 12, 2014
• Study Start: July 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: February 1, 2019
• Last Updated: April 16, 2020
• Results First Posted: February 27, 2020

Record last verified: 2020-04

Locations

US (1)